(105 days)
Not Found
No
The 510(k) summary describes a disposable surgical gown and its physical properties and testing, with no mention of AI or ML.
No
Explanation: The device, a Disposable Surgical Gown, is intended for barrier protection against microorganisms and fluids during surgical procedures, not for treating a disease or condition.
No
Explanation: The device is a surgical gown intended for barrier protection, not for diagnosing medical conditions.
No
The device description explicitly states the device is a surgical gown made of physical materials (SMS nonwoven +TPU membrane, PP and Polyester fiber) and manufactured using physical techniques (Ultrasonic welding and Sewing). It also describes physical barrier properties and undergoes physical performance testing. This is clearly a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "Disposable Surgical Gown" intended to be worn by operating room personnel to protect against the transfer of microorganisms, body fluids, and particulate material. This is a barrier protection function, not a diagnostic function.
- Device Description: The description reinforces the barrier function and mentions materials and manufacturing techniques relevant to a garment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
- Performance Studies: The performance studies focus on physical properties (barrier performance, strength, flammability) and biocompatibility, which are relevant to a surgical gown, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This surgical gown does not perform such a function.
N/A
Intended Use / Indications for Use
Disposable Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile.
Product codes
FYA
Device Description
The subject devices are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate materials.
In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The proposed device is single use, disposable medical devices and provided sterile.
The main materials of device are SMS nonwoven +TPU membrane, PP and Polyester fiber, and the main manufacturing technique are Ultrasonic welding and Sewing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel / operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ISO 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
-
ASTM F2407-06, Standard Specification For Surgical Gowns Indented For Use In Healthcare Facilities.
-
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities.
-
ISO 11135-1:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 127 | Water resistance Hydrostatic Pressure | >50 cm | Passed |
| AATCC 42 | Water Resistance impact penetration Nonwoven and plastic Barriers | ≤1.0 g | Passed |
| ASTM D5034-09 | Tensile Strength | MD Mean≥30 lbs; CD Mean≥25 lbs | Passed |
| ASTM D5587-19 | Tearing Strength | MD Mean≥9 lbs; CD Mean≥18 lbs | Passed |
| ASTM F1868-17 | Evaporative Resistance of fabrics | Mean Evaporative Resistance (Ref)≥0.06(kPa·m2/W). | Passed |
| 16 CFR 1610 | Flammability testing | Meets requirements of Flame Resistant CPSC 1610 Class 1 | Meets requirements |
| ASTM D1683-17 | Seam Strength | >50N | Passed |
| ASTM F1671 | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage ASTM F1671 | No virus through, “None Seen” | Passed |
| ISO 9073-10:2003 | Lint and Other particles generation in the dry state | Log 10 | Bacterial Endotoxin Test |
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2022
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Ray Wang Gerneral Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912 Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K214088
Trade/Device Name: Disposable Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: March 10, 2022 Received: March 15, 2022
Dear Ray Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian, M.D., Ph.D Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K214088
Device Name Disposable Surgical Gown
Indications for Use (Describe)
Disposable Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
The assigned 510(k) Number: K214088
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
-
- Date of Preparation: 2022/04/12
-
- Sponsor Identification
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
No.567, Gushan Road, Area of Economy And Technique, 264207, Weihai City, Shandong, P.R.China Contact Person: Bin Dong Position: Manager Tel: +86-0631-3636942 Fax: +86-0631-3636910 Email: dbfeel@163.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Disposable Surgical Gown Common Name: Gown, Surgical
Regulatory Information Classification Name: Gown, Surgical Classification: 2 Product Code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
Indication For Use Statement:
Disposable Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile.
5. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K173847 Product Name: Disposable Ultra Reinforced Surgical Gown Manufacturer: Xiantao Rayxin Medical Products Co., ltd.
Device Description 6.
The subject devices are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate materials.
In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The proposed device is single use, disposable medical devices and provided sterile.
The main materials of device are SMS nonwoven +TPU membrane, PP and Polyester fiber, and the main manufacturing technique are Ultrasonic welding and Sewing.
-
- Summary of Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- Summary of Non-Clinical Testing
5
-
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ISO 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
-
ASTM F2407-06, Standard Specification For Surgical Gowns Intended For Use In Healthcare Facilities.
-
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities.
-
ISO 11135-1:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 127 | Water resistance | ||
| Hydrostatic Pressure | >50 cm | Passed | |
| AATCC 42 | Water Resistance impact | ||
| penetration Nonwoven and | |||
| plastic Barriers | ≤1.0 g | Passed | |
| ASTM D5034-09 | Tensile Strength | MD Mean≥30 lbs; | |
| CD Mean≥25 lbs | Passed | ||
| ASTM D5587-19 | Tearing Strength | MD Mean≥9 lbs; | |
| CD Mean≥18 lbs | Passed | ||
| ASTM F1868-17 | Evaporative Resistance of | ||
| fabrics | Mean Evaporative | ||
| Resistance | |||
| (Ref)≥0.06(kPa·m2/W). | Passed | ||
| 16 CFR 1610 | Flammability testing | Meets requirements of | |
| Flame Resistant CPSC | |||
| 1610 Class 1 | Meets | ||
| requirements | |||
| ASTM D1683-17 | Seam Strength | >50N | Passed |
| ASTM F1671 | Resistance to Penetration | ||
| by Blood-Borne Pathogens | |||
| Using | |||
| Phi-X174 | |||
| Bacteriophage | |||
| ASTM F1671 | No virus through, “None | ||
| Seen” | Passed | ||
| ISO 9073-10:2003 | Lint and Other particles | ||
| generation in the dry state | Log 10 | Bacterial Endotoxin Test | 50 cm |
| Water Impact (g) | |||
| AATCC-42 | ≤1.0 g | ≤1.0 g | SAME |
| Seam Strength | >58 N | Not Known | / |
| Linting | Log 10 |